PMID- 32625974
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 1831-4732 (Electronic)
IS  - 1831-4732 (Linking)
VI  - 16
IP  - 7
DP  - 2018 Jul
TI  - Safety and efficacy of COXAM((R)) (amprolium hydrochloride) for chickens for 
      fattening and chickens reared for laying.
PG  - e05338
LID - 10.2903/j.efsa.2018.5338 [doi]
LID - e05338
AB  - The coccidiostat amprolium hydrochloride from COXAM ((R)) is considered safe for 
      chickens for fattening at 125 mg/kg complete feed. The margin of safety is at 
      least 5. This conclusion is extended to chickens reared for laying. Amprolium 
      hydrochloride does not possess any significant antibacterial activity. The 
      applicant provided no information on the absorption, distribution, metabolism and 
      excretion (ADME) and on the toxicology of the additive or active substance. 
      Reference was made to the Committee for Medicinal Products for Veterinary Use 
      (CVMP) summary reports from 1999 and 2001 citing studies used for the 
      establishment of maximum residue limits (MRLs) for amprolium. However, the 
      original data used in these assessments were not provided and the literature 
      review covering the subsequent period was not made. Thus, the FEEDAP Panel cannot 
      independently evaluate all data relevant to the current application and is 
      therefore unable to conclude on the safety for the consumer of amprolium when 
      used as a feed additive in chickens for fattening and chickens reared for laying. 
      COXAM ((R)) is considered to be a skin and respiratory sensitiser. Inhalation 
      exposure to dust from COXAM ((R)) may present a risk for the user. The use of 
      amprolium hydrochloride from COXAM ((R)) in feed for chickens for fattening up to 
      125 mg/kg complete feed does not pose a risk for the environment. This conclusion 
      can be extended to chickens reared for laying because of the lower predicted 
      concentration in soil. COXAM ((R)) was effective as a coccidiostat in three floor 
      pen studies and in two anticoccidial sensitivity tests. Since three anticoccidial 
      sensitivity tests showing positive effects of the treatment are required, the 
      FEEDAP Panel is not in the position to conclude on the efficacy of COXAM ((R)) for 
      chickens for fattening under EU farming conditions. Consequently, a conclusion on 
      the efficacy for chickens reared for laying is also not possible.
CI  - (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and 
      Sons Ltd on behalf of European Food Safety Authority.
CN  - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
FAU - Rychen, Guido
AU  - Rychen G
FAU - Aquilina, Gabriele
AU  - Aquilina G
FAU - Azimonti, Giovanna
AU  - Azimonti G
FAU - Bampidis, Vasileios
AU  - Bampidis V
FAU - Bastos, Maria de Lourdes
AU  - Bastos ML
FAU - Bories, Georges
AU  - Bories G
FAU - Chesson, Andrew
AU  - Chesson A
FAU - Cocconcelli, Pier Sandro
AU  - Cocconcelli PS
FAU - Flachowsky, Gerhard
AU  - Flachowsky G
FAU - Kolar, Boris
AU  - Kolar B
FAU - Kouba, Maryline
AU  - Kouba M
FAU - Lopez-Alonso, Marta
AU  - Lopez-Alonso M
FAU - Lopez Puente, Secundino
AU  - Lopez Puente S
FAU - Mantovani, Alberto
AU  - Mantovani A
FAU - Mayo, Baltasar
AU  - Mayo B
FAU - Ramos, Fernando
AU  - Ramos F
FAU - Saarela, Maria
AU  - Saarela M
FAU - Villa, Roberto Edoardo
AU  - Villa RE
FAU - Wallace, Robert John
AU  - Wallace RJ
FAU - Wester, Pieter
AU  - Wester P
FAU - Brantom, Paul
AU  - Brantom P
FAU - Halle, Ingrid
AU  - Halle I
FAU - van Beelen, Patrick
AU  - van Beelen P
FAU - Holczknecht, Orsolya
AU  - Holczknecht O
FAU - Vettori, Maria Vittoria
AU  - Vettori MV
FAU - Gropp, Jurgen
AU  - Gropp J
LA  - eng
PT  - Journal Article
DEP - 20180711
PL  - United States
TA  - EFSA J
JT  - EFSA journal. European Food Safety Authority
JID - 101642076
PMC - PMC7009648
OTO - NOTNLM
OT  - COXAM(R)
OT  - amprolium hydrochloride
OT  - chickens for fattening
OT  - chickens reared for laying
OT  - coccidiostat
OT  - efficacy
OT  - safety
EDAT- 2018/07/11 00:00
MHDA- 2018/07/11 00:01
PMCR- 2018/07/11
CRDT- 2020/07/07 06:00
PHST- 2020/07/07 06:00 [entrez]
PHST- 2018/07/11 00:00 [pubmed]
PHST- 2018/07/11 00:01 [medline]
PHST- 2018/07/11 00:00 [pmc-release]
AID - EFS25338 [pii]
AID - 10.2903/j.efsa.2018.5338 [doi]
PST - epublish
SO  - EFSA J. 2018 Jul 11;16(7):e05338. doi: 10.2903/j.efsa.2018.5338. eCollection 2018 
      Jul.